MSAT Expert — Oral Solid Drug Product (CMVD)

Servier Group; Suresnes; Presencial; EUR 120.000 - 160.000; Jornada completa

Descripción de la vacante

Servier seeks a high‑caliber MSAT Oral Solid Drug Product Expert CMVD Monotherapy to lead technical stewardship across lifecycle, including tech transfers and regulatory support. You will partner with internal sites and external CMOs to ensure robust manufacturing, quality, and compliance for CMVD oral solid products.

The role requires deep formulation knowledge, hands-on experience with scale‑up and process verification, and strong cross‑functional leadership in a global matrix.

Formación

• Experience in CMVD or related oral solid dosage formulation and manufacturing support.
• Experience with regulatory submissions and GMP/ICH guidelines.
• Strong knowledge of blending, granulation, coating, compression and containment.
• Proven track record in tech transfers, deviations, and change controls.
• Excellent written and oral communication; able to work globally.
• Ability to lead cross-functional teams and manage multiple projects.

Responsabilidades

• Act as the technical process owner for CMVD monotherapy products.
• Provide technical oversight of manufacturing processes at internal and external sites.
• Lead internal cross-functional Technical Teams; manage agendas and follow-up.
• Lead or support deviation investigations, root cause analyses, and CAPA definitions.
• Maintain CPV and process monitoring for assigned products across sites.
• Build and maintain MSAT knowledge repository for products and processes.
• Lead or support tech transfers, scale changes, PPQ, and launch readiness.
• Conduct process fit assessments, risk evaluations, and FMEA as part of lifecycle strategy.
• Support regulatory documentation and ensure GMP/ICH alignment.

Conocimientos

GMP knowledge

Regulatory submissions

Cross-functional leadership

Project management

Statistical analysis (Minitab/JMP)

Tech transfers & CAPA

Quality systems understanding

Strong communication

Educación

Bachelor’s Degree in Pharmaceutical Sciences or Chemical Engineering

Master’s or PhD in Pharmaceutical Sciences or Chemical Engineering

Herramientas

Tablet presses

Capsule filling equipment

Fluid-bed coaters

Granulation equipment

Process validation tooling

Descripción del empleo

Servier seeks a high‑caliber MSAT Oral Solid Drug Product Expert CMVD Monotherapy to lead technical stewardship across lifecycle, including tech transfers and regulatory support. You will partner with internal sites and external CMOs to ensure robust manufacturing, quality, and compliance for CMVD oral solid products.

The role requires deep formulation knowledge, hands-on experience with scale‑up and process verification, and strong cross‑functional leadership in a global matrix.